Stifel on Thursday initiated coverage on Immunic Inc. (NASDAQ:IMUX), a late-stage biotechnology company developing oral therapies for neurologic and gastrointestinal diseases.
The company’s lead development program, vidofludimus calcium (IMU-838 or VidoCa), is currently in phase 3 trials for relapsing multiple sclerosis.
Top-line data from the twin phase 3 ENSURE-1 and ENSURE-2 trials in relapsing multiple sclerosis is expected by the end of 2026.
Subsequently, Immunic plans to submit a marketing application in the U.S. in mid-2027, with a targeted potential regulatory approval date in 2028.
Differentiated Path For VidoCa In Crowded MS Market
Stifel initiated coverage with a Buy rating and a price forecast of $2.50, arguing that VidoCa’s oral therapy could carve out a meaningful share in the multiple sclerosis (MS) market by improving on existing safety profiles.
Analyst Paul Matteis highlighted that the core investment thesis centers on replicating the efficacy of Sanofi SA’s (NASDAQ:SNY) Aubagio (teriflunomide) while avoiding its well-documented safety concerns.
These include hepatotoxicity, alopecia, embryofetal toxicity, and neutropenia—issues that have limited broader adoption despite strong efficacy.
Safety Differentiation Seen As Key Driver
Matteis noted that available data and supporting arguments suggest VidoCa has the potential to differentiate across several of these safety parameters.
If validated, key opinion leaders (KOLs) expect the drug to emerge as an attractive option, particularly for older patients, where tolerability and risk management are critical factors in treatment selection.
The analyst emphasized that safety improvements alone could position VidoCa as a viable alternative in a segment of the market that remains sensitive to adverse effects.
Crowded Market Remains Core Bear Case
Skeptics point to the highly competitive nature of the MS market as a primary risk. However, Matteis countered that this dynamic is not new.
The space has been crowded for over a decade, yet Aubagio still generated more than $2 billion in revenue in 2020 despite competing with therapies such as Tecfidera, Gilenya, Tysabri, and the established ABCR class.
This historical precedent suggests that differentiated profiles can still gain traction even in saturated therapeutic areas.
Immunic Positioning Against Established Therapies
Another concern revolves around how VidoCa would position itself relative to Roche Holdings AG’s (OTC:RHHBY) Ocrevus (ocrelizumab) and a growing pool of generic options.
Despite this, KOLs identified potential pockets of opportunity if clinical data holds up, pointing to Biogen Inc.’s (NASDAQ:BIIB) Vumerity (diroximel fumarate) as a conservative benchmark for how newer entrants can establish themselves without directly displacing dominant therapies.
IMUX Price Action: Immunic shares were up 1.00% at $1.01 at the time of publication on Friday, according to Benzinga Pro data.
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